Surgery Clinical Trial
— MSvsMTOfficial title:
Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery
| NCT number | NCT04350697 |
| Other study ID # | MSvsMT |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 1999 |
| Est. completion date | December 31, 2025 |
There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.
| Status | Recruiting |
| Enrollment | 2425 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | Inclusion Criteria: - Indication for Aortic and/or Aortic Valve surgery Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Massimo Bonacchi | Florence |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florence | Dr Aleksander Dokollari, Prof Edvin Prifti, Prof Guido Sani, Prof Sandro Gelsomino |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PO | Post-Operative Survival | 1 day after surgery | |
| Secondary | EO | Early Outcome (Survival) | 1 month after surgery | |
| Secondary | MO | Mid-term Outcome (Survival) | 5 years after surgery | |
| Secondary | LO | Late Outcome (Survival) | 10 years after surgery | |
| Secondary | VLO | Very-Late Outcome (Survival) | 20 years after surgery |
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